FDA 510(k) Application Details - K180214

Device Classification Name	Endoscopic Injection Needle, Gastroenterology-Urology   More FDA Info for this Device
510(K) Number	K180214
Device Name	Endoscopic Injection Needle, Gastroenterology-Urology
Applicant	URO-1, Inc. 391 Technology Way Suite 168 Winston Salem, NC 27101 US Other 510(k) Applications for this Company
Contact	Thomas Lawson Other 510(k) Applications for this Contact
Regulation Number	876.1500   More FDA Info for this Regulation Number
Classification Product Code	FBK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/25/2018
Decision Date	05/03/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review